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Consent Guidelines

Informed Consent

Based on the governing principles of human research outlined in "The Belmont Report," investigators have key responsibility for ensuring voluntary participation of research subjects. The recruitment plan and consent process must be carefully designed so that subjects’ consent will be well-informed and freely given.

Any prospective research subject (or his/her legally authorized representative) should be able to understand as completely as possible what procedures, risks, benefits, alternatives and rights are involved, and make the choice about being in the study without pressure or undue inducement to participate. Free and informed consent is not one-time event, but an ongoing process.

With few exceptions, researchers must obtain and document consent from the prospective research subject before initiating any screening or study procedures. Any exceptions must be reviewed and approved by the IRB beforehand.

Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

As a reminder, the consent form is one part of the entire consent process. The consent document serves as a written summary of the information that was presented and is a useful reference for the subject and the investigator.

There are special consent considerations and requirements for research that involves certain vulnerable populations, such as children or pregnant women.

Other IRBs’ Consent Form Requirements

The UCSF IRB is willing to rely on other specified IRBs in limited circumstances. The IRB also is willing to consider accepting and reviewing consent forms not written in the UCSF format in certain circumstances in which the form has been or will be approved by another duly constituted IRB.

In the Section 1.8 of the Initial Review Submission Packet (special processing instructions), explain your request to use a consent form in a non-UCSF format. See Working With Other Institutions for additional information.